Given the slow roll out of testing for COVID-19 in the U.S., and concerns about spreading the disease, at-home testing could help to diagnose more cases. After initially limiting testing to one provided by the Centers for Disease Control and conducted at state and local public health labs, the Food and Drug Administration allowed certified labs, including commercial lab testing companies, to develop and distribute COVID-19 tests on Feb. 29. Though other private companies have been involved with creating tests for COVID-19, this is the first company to offer its test directly to consumers.
The Austin-based Everlywell offers a range of validated tests for everything from cholesterol levels to fertility and infectious diseases like STDs.
People can order the Everlywell COVID-19 test on the company’s website, after first answering questions about their basic health, symptoms and risk factors for the coronavirus disease. A doctor still needs to prescribe the test, so telemedicine doctors from PWNHealth, a national network of physicians who prescribe diagnostic tests, then reviews these answers to determine if a person qualifies for testing, based on criteria established by the Centers for Disease Control and Prevention. Currently, because COVID-19 tests are not plentiful in the U.S., doctors are trying to rule out other respiratory diseases like flu first, and only ordering tests for people with symptoms who also have other risk factors for infection, such as being in close contact with others who have been diagnosed.
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If the telemedicine doctor decides to prescribe an Everlywell COVID-19 test, the company says it will send the $135 test kit in two days (customers can pay $30 more to receive the kit overnight). The kit comes with a special swab that is long enough to take samples from the back of the nose and throat area, along with instructions for how to seal the swab sample to send it back to the company. People can also provide both spit and sputum samples as backups. (For now, the Food and Drug Administration only validates samples from nasoparyngeal swabs, but companies have applied to test spit and sputum.).
The sample is sent in a pre-paid overnight package, and processed at one of several labs approved by the FDA to perform the test around the country within 72 hours. As with many of the commercially available tests, this one extracts SARS-CoV-2, the virus behind COVID-19, from the sample and then probes for specific genetic signatures of the virus.
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The company says it will then send results by text and email, and doctors may advise people to self-isolate until they receive them. If the test is positive, the company also provides a full telemedicine consultation with one of around 200 physicians that is included in the cost of the test. That physician also reports the result as a positive case to the appropriate state health departments, as is required by health authorities.
Everlywell says it is ready to ship 30,000 COVID-19 tests, and plans to expand the number of labs processing the samples. But CEO and founder Julia Cheek says that scaling up the number of testing kits will depend on the availability of swabs for collecting samples. Three major manufacturers make the swabs, but the main producer, it turns out, is a company based in Italy. Because the country is under lockdown, limited supplies from there, as well as the surge in demand as more COVID-19 testing is conducted around the world, are leading to a global shortage of swabs for any lab performing the test. That’s why Everlywell’s first kits will contain only one swab, and Everlywell will limit kits to one per household until the supply of swabs becomes more plentiful.
“We’re working hard to ramp up weekly capacity to test 250,000 Americans,” says Cheek. “Our goal is to continue to refresh capacity but with the global swab shortage we don’t have a confirmed timeline for that yet. Ultimately, she says, the testing kits could be designed for a household so everyone in a family could be tested if needed to know what protective measure they might need to take.
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